Cleared Traditional

K121674 - ASPIRE HD PLUS, ASPIRE HD-S

K121674 is an FDA 510(k) clearance for ASPIRE HD PLUS, manufactured by Fujifilm Medical System U.S.A., Inc.. The device is a Class 2 Radiology device with product code MUE cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K121674 · Fujifilm Medical System U.S.A., Inc. · Radiology device
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Sep 2012
Decision
107d
Days
Class 2
Risk

K121674 is an FDA 510(k) clearance for the ASPIRE HD PLUS, ASPIRE HD-S. Classified as Full Field Digital, System, X-ray, Mammographic (product code MUE), Class II - Special Controls.

Submitted by Fujifilm Medical System U.S.A., Inc. (Stamford, US). The FDA issued a Cleared decision on September 21, 2012 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1715 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Fujifilm Medical System U.S.A., Inc. devices

FDA 510(k) Submission Details - K121674

510(k) Number K121674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2012
Decision Date September 21, 2012
Days to Decision 107 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 107d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MUE Device Classification - Class 2, Special Controls

Product Code MUE Full Field Digital, System, X-ray, Mammographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1715
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - MUE Full Field Digital, System, X-ray, Mammographic

All 54
Devices cleared under the same product code (MUE) and FDA review panel - the closest regulatory comparables to K121674.
MICRODOSE SI
K123995 · Philips Digital Mammography Sweden AB · Feb 2013
CONTRAST ENHANCED DIGITAL MAMMOGRAPHY
K123873 · Hologic, Inc. · Jan 2013
PLANMED NUANCE DIGIGUIDE
K121963 · Planmed OY · Nov 2012
KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM (USING CARESTREAM CR MAMMOGRAPHY CASSETTE WITH SNP-M1 SCREEN)
K120246 · Carestream Health, Inc. · Aug 2012
PHILIPS MICRODOSE
K120255 · Philips Digital Mammography Sweden AB · Apr 2012
KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM
K110717 · Konica Minolta Medical & Graphic, Inc. · Dec 2011